The aim of this study is to examine the effectiveness of a nurse-coordinated Cardiac Care Bridge program consisting of care coordination, cardiovascular risk management and home-based rehabilitation for high-risk cardiac patients of 70 years and…
ID
Source
Brief title
Condition
- Other condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Health condition
In deze studie zullen patiënten met alle cardiologische aandoeningen worden geïncludeerd op zowel de afdelingen cardiologie als cardiothoracale chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A composite endpoint of unplanned hospital readmission and mortality up to six
months after randomizaton
Secondary outcome
Readmissions and mortality within three and twelve months after randomization
ADL-functioning
iADL-functioning
Functional capacity
Medication adherence
Anxiety
Depression
Health-related quality of life
Symptom burden
Healthcare utilization (Regular community care, primary care visits, emergency
department visits, hospital readmissions and institutionalization)
Caregiver burden
Background summary
After an admission for heart disease, patients are at high risk for adverse
health outcomes such as readmission and death. In the United States 19.9% of
patients with acute myocardial infarction and 24.6% of patients with heart
failure (HF) of 65 years and older are readmitted within 30 days after
discharge. Within this period, 16.6% and 11.2% of these patients is deceased,
respectively. This risk of readmissions and mortality is the highest in the
first weeks after the cardiac admission. Risk factors for these adverse
outcomes are older age, an unplanned admission in the previous six months,
comorbidities and low socioeconomic status. In many patients more health
conditions are often present, such as dizziness, impairments in activities of
daily living, malnutrition and cognitive impairment. These conditions are also
more common in older and cardiac patients and are associated with a higher risk
of readmissions, which in turn may result in the onset of new disabilities and
death.
In the phase of transitions from one care-setting to another, patients are at
risk to adverse health outcomes, e.g. because of medication-related problems,
lack of communication between healthcare providers and unmet needs. In
addition, after an admission patients are often deconditioned, fatigued and
cognitively impaired. These factors increase the risk for readmission and other
adverse outcomes. Further, patients need to adopt to new cardiovascular
medication regimes and to changes in their lifestyle to prevent for recurrent
cardiovascular events. After discharge, the focus is on cardiovascular risk
management, often with inadequate attention to wider healthcare needs. In
high-risk cardiac patients, this may lead to insufficient medical care, such as
to non-attendance of cardiac rehabilitation. This rehabilitation is organized
and coordinated by secondary care providers. In primary care, there is no
alternative care coordination for patients that currently do not receive
rehabilitation in secondary care. As rehabilitation is also effective for these
older cardiac patient with high risk of functional loss, there is a need for
care coordination and an alternative rehabilitation program in primary care.
The transitional care model is developed to ensure continuity of care during
inter-setting transitions and to bridge the gap between hospital and other
settings, which are aimed at decreasing the risk of adverse health outcomes. We
hypothesize that older cardiac patients at high risk of adverse health
outcomes, such as functional decline, readmissions and mortality, may benefit
from care coordination in the transitional phase.
Study objective
The aim of this study is to examine the effectiveness of a nurse-coordinated
Cardiac Care Bridge program consisting of care coordination, cardiovascular
risk management and home-based rehabilitation for high-risk cardiac patients of
70 years and older on reducing unplanned hospital readmission and mortality
within six months after randomization in comparison to care as usual.
Study design
Single-blind randomized controlled trial on patient-level
Intervention
The intervention starts during the admission for patients randomized to the
intervention group (within 72 hours after hospital admission). A personalized,
integrated care plan based on identified problems in the CGA will be
established by a disease manager together with the patient. The department of
geriatrics will be consulted in case of >= 1 identified problem on the
psychological domain or >= 5 identified geriatric problems in general. Also
other disciplines may be consulted in case of signaled geriatric problems. The
integrated care plan will be used during and after discharge.The disease
manager will announce the patient by the community care nurse and the primary
care physiotherapist (PT). The community care nurse (CCRN) visits the patient
during the admission and will receive a detailed discharge summary of the
disease manager about the cardiac condition of the patient and the personalized
goals established from the integrated care plan.
After discharge, care is continued at home by the CCRN and PT. The intensity of
these visits is the highest in the first month after discharge as it is known
that in this period patients are at highest risk of functional loss,
readmission and mortality. In total, the CCRN will visit the patient four to
five times after discharge. On indication, the CCRN may change the week of
visit, for example because of changes in health status. If necessary, the
patient may always consult the CCRN by phone. Core components of the home
visits by the CCRN are the evaluation of the integrated care plan goals,
cardiovascular risk management with attention for medication reconciliation,
lifestyle promotion and progress in cardiac rehabilitation. The CCRN consults
other disciplines if needed. If patients, are readmitted in a participating
hospital and ward during the study follow-up of twelve months, they will
receive the Cardiac Care Bridge program again from the start.
After discharge, the PT will visit the patient a total of nine times for two
times per week for home-based cardiac rehabilitation according to the Dutch
multidisciplinary guideline of cardiac rehabilitation. Depending on their
functional status, patients will start with functional rehabilitation, focusing
on muscle strength and body balance. If patients are able to, the
rehabilitation program is intensified by endurance training by a graded
exercise protocol. The last rehabilitation visit is made to evaluate the
current functional status and to refer patients to additional physiotherapy in
primary care or to a cardiac rehabilitation center. The rehabilitation
component of the Cardiac Care Bridge program will not be repeated in case of
readmissions during the follow-up period of 12 months. This is due to a
limitation in the number of physical therapy sessions in Dutch healthcare
insurance policies.
Study burden and risks
We expect that this study will have a negligible risk. As described earlier,
home-based cardiac rehabilitation is proven to be as safe as center-based
cardiac rehabilitation. Therefore, no extra risks are expected because of the
rehabilitation component in this study. All involved healthcare professionals
who are not (recently) trained in reanimation, will be offered a reanimation
training.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Cardiac patients of 70 years and older
- Admitted to the departments of cardiology or cardiothoracic surgery
- Electively and non-electively
- Admission > 48 hours
- Hisk of functional loss according to the screening-tool for frailty of the
Dutch Safety Management Program (screening on ADL-functioning, fall risk,
malnutrition and delirium) and/or an unplanned admission in the previous six
months
- Mini-Mental Examination Score (MMSE) >= 15
Exclusion criteria
- Congenital heart disease
- Terminal illness: defined as a life expectancy of less than three months, for
example because of cancer or terminal heart failure.
-Transferred from or to a nursing home
-Transferred to another hospital not participating in this study
- Unable to communicate in Dutch
- Delirium as confirmed by the treating physician
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL55636.018.16 |